1 HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment 
American Sales Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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American Sales Company 1% Hydrocortisone Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
eczema
psoriasis
poison ivy, oak, sumac
insect bites
detergents
jewelry
cosmetics
soaps
seborrheic dermatitis
temporarily relieves external anal and genital itching
other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do not use

in the genital area if you have a vaginal discharge. Ask a doctor.
for the treatment of diaper rash. Ask a doctor.

When using this product

avoid contact with the eyes
do not use more than directed unless told to do so by a doctor
do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
rectal bleeding occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

for itching of skin irritation, inflammation, and rashes:
adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 2 years of age: do not use, ask a doctor
for external anal and genital itching, adults:
when practical, clean the affected area with mild soap and warm water and rinse thoroughly
gently dry by patting or blotting with toilet tissue or a soft cloth before applying
apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe barbadensis leaf juice, white petrolatum

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Cortizone●10®

MAXIMUM STRENGTH

1% HYDROCORTISONE

ANTI-ITCH OINTMENT

Relieves Itch Fast

Skin Irritation – Rashes- Insect bites – Eczema & Psoriasis – Inflammation & Redness

Water resistant formula helps seal in healing

NET WT 1 OZ (28 g)

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1 HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-201
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
Color WHITE (clear) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-201-64 1 in 1 CARTON
1 28 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 10/17/2012
Labeler - American Sales Company (809183973)

Revised: 10/2013
Document Id: d3c495fe-e59b-42f6-b986-dee266ae3c18
Set id: 1b5091e1-1800-4f48-9efc-c045222f8885
Version: 2
Effective Time: 20131010
 
American Sales Company